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Substances that should be restricted

7.2 Analysis

7.2.4 Substances that should be restricted

Summary

· Using EU-LCI values means using health-based reference concentrations which are derived on a scientific basis with a view to promote standard assessments throughout the EU of emissions of volatile organic compounds (VOC) from construction products.

· The VOC standard, which is expected to be adopted as a harmonised standard, is a natural starting point for selecting substances which should be regulated.

· With regard to regulating semi-volatile organic compounds (SVOC) with particularly hazardous characteristics, different starting points can be used:

o substance-specific regulation based on LCI values for SVOCs with CMR characteristics;

o restriction on all SVOCs with CMR characteristics.

133 The “New approach” means, in a nutshell, that detailed technical requirements are avoided in the product directives in favour of essential health-related and safety requirements and references to standards. A product which has been manufactured according to a harmonised standard is assumed to fulfil the essential requirements in the relevant directive. The New approach was supplemented in 1993 by the introduction of a holistic method for assessing compliance. This method includes harmonised methods for testing, certification and CE marking. Manufacturers were given greater responsibility and options for indicating how the product fulfils the essential requirements.

The 46 substances identified in the consultant’s study do not provide an exhaustive inventory of harmful substances in the construction sector, but the results from the consultant’s study and can be regarded as known examples. Therefore, national regulations should also include other substances which have been identified as relevant in the analysis of emissions from construction products and which have an impact on health. However, it is interesting to note that 32 of the 46 substances are regulated in Germany, France or Belgium, see Table 6. Table 6: Substances identified in national legislation from the 46 chemicals harmful to health in the consultant’s study, which are used in the EU construction sector.

Identified substances (CAS/ Name) DE FR BE Identified substances (CAS/ Name) DE FR BE 110-71-4 1,2-Dimethoxyethane x x 108-95-2 Phenol x x

106-46-7 1,4-Dichlorobenzene x x 50-00-0 Formaldehyde x x x

123-91-1 1,4-Dioxane x x 98-01-1 Furfural x x

111-96-6 Diethylene glycol dimethyl ether x x 111-30-8 Glutardialdehyde (1,5-

Pentanedial) x x

2210-79-9 2,3-Epoxypropyl o-tolyl ether 25637-99-4 Hexabromocyclododecane

128-37-0 Butylated Hydroxy Toluene

(BHT) x x 63449-39-8 Chloroparaffin

96-29-7 2-Butanonoxime x x 85535-85-9 Chloroparaffins, C14-17

110-80-5 2-Ethoxyethanol x x 91-20-3 Naphthalene x x

111-15-9 2-Ethoxyethyl acetate x x 2687-91-4 N-Ethyl-2-pyrrolidone x

149-57-5 2-Ethylhexanoic acid x x 110-54-3 n-Hexane x x

70657-70-4 2-Methoxypropyl acetate x x 872-50-4 N-Methyl-2-pyrrolidone x x

1589-47-5 2-Methoxy-1-propanol x x 556-67-2 Octamethylcyclotetrasiloxane x x

109-86-4 2-Methoxyethanol x x 100-42-5 Styrene x x x

110-49-6 2-Methoxyethyl acetate x x 79-94-7 Tetrabromobisphenol A

75-07-0 Acetaldehyde x x x 109-99-9 Tetrahydrofuran x x

79-06-1 Acrylamide 127-18-4 Tetrachloroethylene x x

107-13-1 Acrylonitrile 56-23-5 Tetrachloromethane x

1163-19-5 Decabromodiphenyl ether 108-88-3 Toluene x x x

80-05-7 Bisphenol A 126-73-8 Tributyl phosphate x

77-58-7 Dibutyltin dilaurate 112-49-2 Triethylene glycol dimethyl ether x x

28553-12-0 Diisononyl phthalate 5064-31-3 Trisodium nitrilotriacetate

68-12-2 Dimethylformamide x x 115-96-8 Tris(2-chloroethyl) phosphate

75-21-8 Ethylene oxide 108-05-4 Vinyl acetate x The VOC standard134, which is expected to be adopted as a harmonised standard, is a natural starting point for selecting substances which should be regulated. The list of VOCs included in the standard is listed in Appendix 8. The standardisation drafts standards for essential characteristics which are regulated in the respective Member State’s legislation. The current VOC standard covers the substances which are regulated in German, French and Belgian legislation, apart from formaldehyde and acetaldehyde. These substances are more suitable to be analysed using a VVOC method.

Using EU-LCI values means using health-based reference concentrations which are derived on a scientific basis with a view to promote standard assessments throughout the EU of emissions of volatile organic compounds (VOC) from construction products. It is more realistic to look at emissions of substances as the contents in a product do not always represent a risk in the indoor environment.

134 prEN 16516 Construction products - Assessment of release of dangerous substances - Determination of emissions into indoor air

One benefit of using EU-LCI values, both for individual substances and for a total hazard ratio (sum of the individual ratios between the measured concentration for individual substances and the substance’s EU-LCI value), is that all the substances which have been assessed and where a value has been derived can be taken into consideration. This means that when the list of substances with LCI values is updated, the substances which need to be measured and included in the total hazard ratio will also be updated. It is also important to have the possibility of keeping the list of LCI values up to date, both with regard to the types of substances and how many substances are included, along with their respective EU-LCI values. New information may emerge, such as data arising via the implementation of the REACH regulation or through national activities. The EU-LCI concept cannot be used for substances where there is a lack of information about health effects or reliable measurement methods are still not available. Germany has included substances which do not have an LCI value by providing a separate emissions limit for these substances.

VOC emissions are regulated in the three countries which have national restrictions

(Germany, France and Belgium), both at a general emissions level based on limit values for total emissions of volatile organic compounds (TVOC, ≤ 1 000 µg/m3) and at a substance- specific level based on LCI values. From a health perspective, individual readings are more important than the TVOC, but the TVOC value can be seen as an indicator since low total emissions of VOCs often, but not always, correlate with a better indoor environment. A value for total emissions of VOCs can help provide information about increased emissions to supplement the health-based assessment of emissions of individual substances (EU-LCI values) and a restriction on substances which are carcinogenic, mutagenic or toxic for reproduction.

The total hazard ratio, known as the R-value, is the sum of the individual ratios between the measured concentration and an LCI value, irrespective of the type of effect caused by the individual substances. At present, there is not sufficient knowledge available to produce effect-specific hazard ratios, but ratios can be viewed as a practical tool for providing a comprehensive look at the total emissions (of substances which have been assessed) from a construction product. Assessing and dealing with combination effects is an area which has been highlighted as a priority, including as part of Sweden’s environmental quality objective Non-toxic environment, which means that the format and use of the hazard ratio may need to be reassessed if new knowledge comes to light.

It may also be necessary to consider additional restrictions, as a suplement to the total hazard ratio, which is a weighted hazard ratio for all substances which have an LCI value and are emitted from a specific construction product. As the hazard ratio (R-value) is expressed with one significant digit (R≤1), this means in practice that a total ratio up to 1.49 is acceptable since the ratio is still rounded down to 1. However, the emission level for each individual substance should not exceed the relevant limit set. Therefore, it may be appropriate for individual ratios to be included where the individual ratio should be expressed with two significant digits (R≤1.0). This means in practice that each single substance’s ratio cannot exceed 1.049.

No additional assessment is required for substances classified as carcinogenic, mutagenic or toxic for reproduction, as the use of these substances should be avoided as far as possible in consumer products and articles. Consequently, it is appropriate to specifically restrict

values have still not yet been derived systematically for carcinogens. The CMR substances which are volatile can be measured using the forthcoming standard for measuring VOCs135. It is important to be able to update the restriction when necessary, for instance when new information comes to light. One example is provided by endocrine disruptors, where criteria have not yet been established to specify when a substance can be regarded as endocrine- disrupting. When these criteria are available, substances which meet the criteria may need to be included in the restriction.

With regard to regulating semi-volatile organic compounds (SVOC) of high concern, different starting points can be used. SVOCs have different inherent physical/chemical characteristics to VOCs, which means that they have a different emissions pattern to that for VOCs. These characteristics also mean that SVOCs are distributed in a different way between air and dust to VOCs, which makes SVOCs more difficult to measure. If air and dust samples are

combined, this gives a more realistic picture of the level of exposure. A generally low concentration limit should be set if sampling is only carried out from the air phase.

One possible restriction is provided by substance-specific regulation based on LCI values for SVOCs with CMR characteristics. The problem with this type of regulation is that it requires a list of the substances included in the restriction. In this case, a format is required which facilitates ongoing updates, such as the EU-LCI list, which also requires a continual process for assessing substances. Another possibility is to restrict all SVOCs with CMR

characteristics.

Phthalates have previously been identified as problem substances to which children can be exposed via dust, with construction products such as flooring having been identified as a source. Phthalates which have been classified as toxic for reproduction, such as DEHP, could be covered by a restriction, regardless of whether the format of the restriction was based on a substance-specific regulation or that all SVOCs with CMR characteristics were used as a basis for the restriction.